Bausch + Lomb Corporation announced that the Journal of Ocular Pharmacology and Therapeutics has published new study results in a paper titled “Comparison of Two Preservative-Free Artificial Tears with Sodium Hyaluronate for Relief of Dry Eye Symptoms: A Randomized, Investigator-Masked Study.”
The Relief of Eye Surface by Triple Action (RESTA) study was a multicenter, randomized, investigator-masked noninferiority trial (NCT03368404) that assessed 79 patients with moderate-to-severe dry eye. It compared Artelac Complete (0.24% sodium hyaluronate + carbomer + medium-chain triglycerides) with a sodium hyaluronate-only comparator (0.18%). Patients were randomized 1:1 and instilled drops three to six times daily for 90 days. The primary endpoint was the change from baseline to Day 28 in total ocular surface fluorescein staining, with secondary endpoints including staining at Day 90, dry eye signs and symptoms, tear film break-up time, Schirmer’s test, quality-of-life measures and instillation frequency.*
Key Findings from the trial1:
- The study results demonstrated Artelac Complete’s non-inferiority to the comparator in improving ocular surface staining at Day 28 (mean OSFS change: 2.07 ± 1.67 vs 1.50 ± 1.64; 95% CI upper limit 0.13).
- Consistent improvements in dry eye signs, symptoms and quality-of-life measures were observed through Day 90, with Artelac Complete showing significantly improved global quality of life (QoL) (P = 0.0306) and gains across several individual QoL parameters.
- Patients using Artelac Complete instilled drops fewer times per day than those using the comparator, suggesting longer-lasting comfort and improved ocular tolerability.
- Both formulations were safe and well tolerated, with no unexpected adverse events reported.
“By combining sodium hyaluronate, carbomer and triglycerides, Artelac Complete was designed to hydrate, protect and stabilize all layers of the tear film,” said the RESTA study’s chief investigator, Professor Marc Labetoulle, head and chair of ophthalmology, Hôpital Bicêtre, Paris-Saclay University. “The study showed that this formulation not only relieves signs and symptoms of dry eye but also provides improvements to patients’ quality of life.”
*The data presented in this release pertain to Artelac products marketed outside the United States.
References
1. Comparison of Two Preservative-Free Artificial Tears with Sodium Hyaluronate for Relief of Dry Eye Symptoms: A Randomized, Investigator-Masked Study. J Ocul Pharmacol Ther. DOI: 10.1177/10807683251391557
